A Study in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria

• Sponsor: Ardelyx (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01847092
• Collaborator: AstraZeneca (Industry)
• Enrollment: 154
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 6.7

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if the study drug is safe, tolerable and active in reducing albuminuria in patients with Chronic Kidney Disease with Type 2 Diabetes.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease; Type 2 Diabetes Mellitus	Drug: AZD1722; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 154 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: An Exploratory Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Design Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AZD1722 in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria
• Study Start Date: May 1, 2013
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: AZD1722 AZD1722 in 5, 15, 30, or 60 mg capsules. Starting dose is 15 mg BID PO for 12 Weeks	Drug: AZD1722
Placebo Comparator: Placebo Placebo capsule BID PO for 12 Weeks	Drug: Placebo; Placebo for AZD1722

Outcome Measures

Primary Outcome Measures

1. Changes in Urine Albumin to Creatinine Ratio (UACR) [Week 12]

   The difference between tenapanor and placebo in the change in UACR from baseline to the end of 12 weeks of treatment

Secondary Outcome Measures

1. Change in Estimated Glomerular Filtration Rate (mL/Min/1.73 m2) From Baseline to Week 12 Endpoint [12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Males or females aged 18 to 80 years, inclusive.

• Body mass index between 18 and 45 kg/m2, inclusive.

• Type 2 diabetes mellitus and receiving ≥1 glucose lowering medication for at least 3 months prior to randomization

• Stage 3 CKD

• MSSBP ≥130 mmHg

• Urinary albumin: mean UACR ≥ 200 mg/g

Exclusion Criteria:

• Urinary albumin: UACR > 3500 mg/g

• History of a renal transplant

• MSSBP >180 mmHg or a MSDBP of >120 mmHg on two occasions during screening or run-in periods

• History of inflammatory bowel disease or diarrhea predominant irritable bowel syndrome

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Creekside Endocrine Associates PC	Denver	Colorado	United States	80209

Sponsors and Collaborators

• Ardelyx
• AstraZeneca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ardelyx
• ClinicalTrials.gov Identifier: NCT01847092
• Other Study ID Numbers: D5610C00001
• First Posted: May 6, 2013
• Last Update Posted: May 27, 2020
• Last Verified: May 1, 2020

• Keywords provided by Ardelyx: albuminuria
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Albuminuria; Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

Participant Flow

Arm/Group Title	AZD1722	Placebo
Arm/Group Description	AZD1722 in 5, 15, 30, or 60 mg capsules. Starting dose is 15 mg BID PO for 12 Weeks AZD1722	Placebo capsule BID PO for 12 Weeks Placebo: Placebo for AZD1722
Period Title: Overall Study
STARTED	77	77
COMPLETED	51	66
NOT COMPLETED	26	11

Baseline Characteristics

Arm/Group Title	AZD1722	Placebo	Total
Arm/Group Description	AZD1722 in 5, 15, 30, or 60 mg capsules. Starting dose is 15 mg BID PO for 12 Weeks AZD1722	Placebo capsule BID PO for 12 Weeks Placebo: Placebo for AZD1722	Total of all reporting groups
Overall Participants	77	77	154
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.6 (8.79)	65.6 (8.77)	65.1 (8.77)
Sex: Female, Male (Count of Participants)
Female	52 67.5%	52 67.5%	104 67.5%
Male	25 32.5%	25 32.5%	50 32.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	18 23.4%	19 24.7%	37 24%
Not Hispanic or Latino	59 76.6%	58 75.3%	117 76%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 1.3%	0 0%	1 0.6%
Asian	1 1.3%	2 2.6%	3 1.9%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	21 27.3%	18 23.4%	39 25.3%
White	53 68.8%	53 68.8%	106 68.8%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 1.3%	4 5.2%	5 3.2%

Outcome Measures

1. Primary Outcome

Title	Changes in Urine Albumin to Creatinine Ratio (UACR)
Description	The difference between tenapanor and placebo in the change in UACR from baseline to the end of 12 weeks of treatment
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AZD1722	Placebo
Arm/Group Description	AZD1722 in 5, 15, 30, or 60 mg capsules. Starting dose is 15 mg BID PO for 12 Weeks AZD1722	Placebo capsule BID PO for 12 Weeks Placebo: Placebo for AZD1722
Measure Participants	77	77
Mean (Standard Deviation) [mg/g]	-64.6 (898.4)	104.8 (668.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AZD1722, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.279
	Comments
	Method	Mixed Models Analysis
	Comments

2. Secondary Outcome

Title	Change in Estimated Glomerular Filtration Rate (mL/Min/1.73 m2) From Baseline to Week 12 Endpoint
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	AZD1722	Placebo
Arm/Group Description	AZD1722 in 5, 15, 30, or 60 mg capsules. Starting dose is 15 mg BID PO for 12 Weeks AZD1722	Placebo capsule BID PO for 12 Weeks Placebo: Placebo for AZD1722
Measure Participants	77	77
Least Squares Mean (Standard Deviation) [mL/min/1.73 m2]	-2.8 (1.21)	-2.7 (1.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AZD1722
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.94
	Comments
	Method	ANCOVA
	Comments

Adverse Events

Time Frame	12 Weeks
Arm/Group Title	AZD1722		Placebo
Arm/Group Description	AZD1722 in 5, 15, 30, or 60 mg capsules. Starting dose is 15 mg BID PO for 12 Weeks AZD1722		Placebo capsule BID PO for 12 Weeks Placebo: Placebo for AZD1722
All Cause Mortality
	AZD1722		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/77 (0%)		0/77 (0%)
Serious Adverse Events
	AZD1722		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/77 (3.9%)		2/77 (2.6%)
Blood and lymphatic system disorders
Deep Vein Thrombosis	1/77 (1.3%)	1	0/77 (0%)	0
Cardiac disorders
Cardiac failure congestive	0/77 (0%)	0	1/77 (1.3%)	1
Investigations
Hyperkalemia	2/77 (2.6%)	2	1/77 (1.3%)	1
Other (Not Including Serious) Adverse Events
	AZD1722		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	45/77 (58.4%)		4/77 (5.2%)
Gastrointestinal disorders
Diarrhea	45/77 (58.4%)	45	4/77 (5.2%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.